Effect of Pulsing Electrical Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study (DPN)
A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
To determine if pulsed electric field therapy reduces lower leg and foot pain associated with diabetic neuropathy and lessens the need for medication.
The MedRelief device sends a sub-threshold electric signal through the skin using electrodes as means of signal delivery. The signal or waveform, frequency and strength were created to match the characteristics of signals the body generates to help natural healing.
研究概览
详细说明
A multi-center, randomized, open-label study involving 23 patients with chronic diabetic peripheral neuropathy meeting study entry criteria. Subjects will be randomly assigned to receive one of two treatments using an FDA cleared MedRelief device: (1) a MedRelief SE 55 device set on "pulsed" mode at 10 microsecond burst intervals 4150 Ha, or (2) a MedRelief SE 55 device set on "continuous" mode at 4150 Hz. Subjects will wear the device on target foot each night for a minimum of 6 hours over a two week (15 day treatment)period.
Subjects will complete a daily pain diary, medication form, and device use form. Subject global assessments and physician global assessments will occur at baseline, study visits Day 7, Day 15 and Day 21 (end of study).
Response to therapy will include pain reduction, improvement in sensation, improved response to vibratory stimulation and reduction of edema in study subjects.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Georgia
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Augusta、Georgia、美国、30909
- Nephrology and Rheumatology Associates
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- currently diagnosed with diabetes mellitus
- confirmed diagnosis of diabetic peripheral neuropathy
- age 18 years to 75 years
- both males and females are eligible for study participation
- HgA1c level under 9
- Physician confirmed stable glycemic control for 3 months prior to enrollment
- baseline pain level over previous month of 5
- willing to sign IRB approved consent and follow study visit requirements
- if female of childbearing age willing to undergo urine pregnancy test
Exclusion Criteria:
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学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：1, 2
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4150 Hz signal continuous or pulse, high intensity, high modulation for 6 hours each night during treatment phase
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Pain reduction in diabetic patients with chronic diabetic neuropathy
大体时间：Day 21
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Day 21
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Improvement in sensation and overall foot condition
大体时间：Day 21
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Day 21
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合作者和调查者
赞助
调查人员
- 首席研究员：Amy M Sprague, MD、Nephrology and Rheumatology Associates
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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